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IMDRF/SaMD WG/N12FINAL:2014 Software as a Medical Device Possible Framework for Risk Categorization and Corresponding Considerations - PDF (243kb)

赵静曼 7/13/2022 浏览 257 IMDRF/SaMD WG/N12 世界

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Software as a Medical Device Possible Framework for Risk Categorization and Corresponding Considerations - PDF (243kb)[附网盘链接]由IMDRF Software as a Medical Device (SaMD) Working Group于18 September 2014发布，适用于世界。

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Software as a Medical Device Possible Framework for Risk Categorization and Corresponding Considerations - PDF (243kb)[附网盘链接]
Software as a Medical Device Possible Framework for Risk Categorization and Corresponding Considerations - PDF (243kb)[附网盘链接](截图)

 

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1.0 Introduction

Software is playing an increasingly important and critical role in healthcare with many clinical

and administrative purposes.

Software used in healthcare operates in a complex socio-technical environment—consisting of

software, hardware, networks, and people—and frequently forms part of larger systems that must

operate in a unified manner. This software frequently depends on other commercial off-the-

shelf (COTS) software and on other systems and data repositories for source data.

A subset of software used in healthcare meets the definition of a medical device; globally,

regulatory authorities regulate such software accordingly.

Existing regulations for medical device software are largely focused on medical device software

that is embedded in dedicated hardware medical devices and are focused around physical harm,

transmission of energy and/or substances to or from the body, the degree of invasiveness to the

body, closeness to sensitive organs, duration of use, diseases, processes and public health risk,

competence of user and effect on population due to communicable diseases, etc.

Today, medical device software is often able to attain its intended medical purpose independent

of hardware medical devices. It is increasingly being deployed on general-purpose hardware and

delivered, in diverse care settings, on a multitude of technology platforms (e.g., personal

computers, smart phones, and in the cloud) that are easily accessible. It is also being

increasingly interconnected to other systems and datasets (e.g., via networks and over the

Internet).

The complexity of medical device software, together with the increasing connectedness of

systems, results in emergent behaviors not usually seen in hardware medical devices.

This introduces new and unique challenges. For example:

• Medical device software might behave differently when deployed to different hardware

platforms.

• Often an update made available by the manufacturer is left to the user of the medical

device software to install.

• Due to its non-physical nature (key differentiation), medical device software may be

duplicated in numerous copies and widely spread, often outside the control of the

manufacturer.

Furthermore, there are lifecycle aspects of medical device software that pose additional

challenges. For instance, software manufacturers often:

• Have rapid development cycles,

• Introduce frequent changes to their software, and

• Deliver updates by mass and rapid distribution.

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